Shares of Immunic stock have plunged more than 70% in premarket trading after an early peek at its Phase Ib psoriasis drug candidate has so far failed to distinguish itself from placebo.
Shares of Immunic stock plunged more than 70% in premarket trading Friday after an early peek at the company’s Phase Ib psoriasis drug candidate showed it has so far failed to distinguish itself from placebo.
Following a pre-planned interim group-level data review for its study assessing IMU-935 in patients with moderate-to-severe psoriasis, New York-based Immunic reported the analysis showed it did not separate itself from placebo after four weeks.
The Phase Ib study assessed IMU-935 at doses of 150 mg once daily and 150 mg twice daily versus placebo. The primary endpoint of this study was the safety and tolerability of IMU-935 in moderate-to-severe psoriasis patients.
The company stated that overall, the analysis showed a greater decrease in the placebo arm’s averages of Psoriasis Area and Severity Index (PASI) reductions.
Immunic noted that as of Friday morning, it only has access to limited information from the study. The interim data showed mean values at group level after four weeks; the company does not have access to unblinded individual patient data.
Immunic shared that pharmacodynamics, pharmacokinetic information and biomarker data, such as skin punches and serum IL-17 levels, are not yet available.
Still, the revelation of the asset failing to separate from placebo was enough for investors. Share prices fell from Thursday’s close of $9.20 to $2.39 before Friday’s opening bell.
Daniel Vitt, president and chief executive officer of Immunic, said that although the initial data is not what the company expected, Immunic still believes in IMU-935’s potential as a therapeutic for psoriasis and other indications.
IMU-935 is a selective inverse agonist of RORγ/RORγt (retinoic acid receptor-related orphan nuclear receptor gamma / truncated). RORγt is believed to play a key role in releasing cytokines in various inflammatory and autoimmune diseases. In preclinical studies, it demonstrated its ability to inhibit cytokines that targeted Th1 and Th17 responses.
“We believe IMU-935 holds the potential to provide a safe, efficacious and meaningful treatment option to patients with psoriasis,” Vitt said in a statement.
Full data from the study will give the Immunic team a better understanding of the early observations in this interim analysis, Vitt added. The full data will also enable the company to determine next steps with IMU-935.
Based on available preclinical data and clinical safety and tolerability data, the company noted it has the flexibility to adjust its trial parameters to consider either higher dosing or longer treatment cohorts.
Disappointing Results Follow Influx of Cash
The announcement comes days after Immunic secured $60 million in private financing that is expected to support the development of IMU-935 and its two other lead assets, IMU-838 (vidofludimus calcium) for multiple sclerosis and IMU-856 for conditions associated with bowel barrier dysfunction.
In June, Immunic released favorable updated results from its Phase II EMPHASIS study evaluating IMU-838 in relapsing-remitting multiple sclerosis. More data is coming from other studies.
Interim Data from the Phase II CALLIPER trial assessing IMU-838 in MS are anticipated in the second half of 2023. Top-line data from that study is expected at the end of 2024. A readout of a Phase III trial in relapsing MS is also expected by 2025.
Initial clinical efficacy data of the Part C portion of the ongoing Phase I study of IMU-856 in celiac disease patients is expected in 2023.
